UK's NICE backs GSK's Hycamtin for cervical cancer and Lilly's Efient for preventing blood clots

28 October 2009

The UK's National Institute for Health and Clinical Excellence (NICE), which recommends treatments to be made available under the National Health Service in England and Wales, has published final guidances, backing GlaxoSmithKline's Hycamtin (topotecan) and Eli Lilly/Daiichi Sankyo's Efient (prasugrel).

The NICE has recommending the use of topotecan in combination with cisplatin as a treatment option for women with recurrent or stage IVB cervical cancer who have not previously received cisplatin.

Women who have previously received cisplatin and are currently being treated with topotecan in combination with cisplatin for recurrent and stage IVB cervical cancer should have the option to continue their therapy until they and their clinicians consider it appropriate to stop. Topotecan prevents DNA replication in cancer cells by inhibiting the enzyme topoisomerase I which helps to separate and repair the DNA in cells when they divide.

In its previous submission to the Scottish Medical Consortium GSK's model estimated the incremental cost-effectiveness ratio (ICER) for oral topotecan plus best supportive care (BSC) compared with BSC alone to be £26,833 per quality life year (QALY) gained, in patients for whom IV chemotherapy was considered unsuitable. The SMC submission notes that the ICER rose to over £30,000 if the assumptions made on quality of life values, drug administration costs, or costs associated with adverse events were changed.

Carole Longson, Health Technology Evaluation Centre Director at the NICE, said: 'The independent Appraisal Committee considered all available evidence on the effectiveness of topotecan as a treatment for women with cervical cancer. They also heard evidence from patients who highlighted the importance of having a number of treatment options because one may be more suitable than others for the individual patient. The committee concluded that - for women with recurrent cervical cancer and those with stage IVB cervical cancer, where cancerous cells have spread to distant organs, such as the lungs, and who have not previously received cisplatin - the cost of topotecan in relation to how well it works is an effective use of NHS resources.'

She added: 'Cervical cancer affects approximately 2,800 women in the UK each year. Currently a range of therapies are used to treat the cancer with no single best practice treatment. Today's guidance means that those patients who meet the above criteria will have a further treatment option'.

NICE guidance recommends option for preventing arterial blood clots in people with acute coronary syndromes

The NICE also recommended the use of prasugrel in combination with aspirin as an option for preventing blood clots in the arteries of people with acute coronary syndromes. The guidance recommends prasugrel in combination with aspirin as an option for individuals who are having percutaneous coronary intervention, only when:

* immediate primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction (a specific type of heart attack) is necessary or
a blood clot blocking a stent has occurred during treatment with a drug called clopidogrel or the patient has diabetes mellitus.

People currently receiving prasugrel for treatment of acute coronary syndromes whose circumstances do not meet these criteria should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

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